Is laser treatment effective for patients with periodontal disease?
| ISRCTN | ISRCTN18400416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18400416 |
| Secondary identifying numbers | Z151100004015100 |
- Submission date
- 08/07/2018
- Registration date
- 11/07/2018
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
In recent years, dental lasers have been used for the non-surgical treatment of periodontal (gum) diseases. However, it is unclear whether lasers are effective at improving treatment for chronic periodontitis (inflammation of the gums). This study aims to determine whether the use of a laser called Er:YAG is more effective than the traditional treatment of scaling and root planing (SRP) for periodontal diseases in a Chinese population.
Who can participate?
Chronic periodontitis patients aged between 35-70 in Beijing
What does the study involve?
The study design involves splitting the patient's mouth into two sides - a test side and a control side. Teeth were randomly allocated into the test side or the control side i.e. if teeth on the left hand side were allocated test group, the right hand side will be the control group. Participants in the test group will receive laser treatment and traditional SRP treatment, whereas participants in the control group will receive traditional SRP treatment only. To determine the effectiveness of the treatment, participants will have a clinical examination involving assessment of their probing depth, clinical attachment level, bleeding index and plaque index. For the test and control groups, treatment will occur at 0 months, 3 months and 6 months. Treatment will occur after a clinical examination.
What are the possible benefits and risks of participating?
A benefit of participating is that patients will receive traditional periodontal treatment, along with free laser treatment for those in the test group. There is the risk of a small amount of pain in the gum for 1-2 days after treatment.
Where is the study run from?
Department of Stomatology, Beijing Chao-Yang Hospital, Beijing
When is the study starting and how long is it expected to run for?
March 2015 to December 2017
Who is funding the study?
1. The Beijing Science and Technology Committee (China)
2. National Natural Science Foundation of China (China)
Who is the main contact?
Prof. Zhou
xuanzhou2004@hotmail.com
Contact information
Scientific
Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Chao Yang District
Beijing
100020
China
 ORCID ID |
0000-0003-2522-1283 |
|---|
Study information
| Study design | Interventional single-blinded single centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy of Er:YAG laser on chronic periodontitis as an adjunctive non-surgical treatment: a split-mouth randomized controlled study |
| Study acronym | Er:YAG laser in Periodontal Treatment |
| Study objectives | Er:YAG laser combined with conventional scaling and root planing (SRP) may provide more effective adjunctive treatment than SRP alone |
| Ethics approval(s) | Ethics Committee of the Beijing Chao-Yang Hospital, 14/11/2014, No: 2014-Sci-157 |
| Health condition(s) or problem(s) studied | Moderate or severe chronic periodontitis |
| Intervention | Using a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus scaling and root planing (SRP) treatment, while the quadrants in the control group received SRP only. |
| Intervention type | Other |
| Primary outcome measure | Periodontal probing was used to measure the following at the baseline, after 3 months and after 6 months: 1. Probing depth (PD) 2. Clinical attachment level (CAL) |
| Secondary outcome measures | The following were measured at the baseline, after 3 months and after 6 months: 1. Bleeding index (BI) assessed through periodontal probing 2. Plaque index (PLI) assessed by an examiner using a scale of 0 to 3 with the following definitions: - 0: No plaque - 1: Cannot see plaque but plaque can be detected with probe - 2: Moderate plaque can be seen - 3: Lots of plaque can be seen |
| Overall study start date | 01/11/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 27 |
| Total final enrolment | 27 |
| Key inclusion criteria | 1. Aged 35-70 years 2. Minimum of 16 teeth (4 per quadrant) 3. At least one site with probing depths (PD) ≥4 mm in each quadrant, with bleeding on probing 4. Good general health 5. Non-smoker |
| Key exclusion criteria | Possible participants were excluded if they 1) had received periodontal treatment within the previous 6 months; 2) had received systemic antibiotic therapy within the previous 6 months; 3) had suffered systemic diseases that could influence the outcome of therapy, such as diabetes mellitus or blood disease; 4) were pregnant; or 5) were smokers. 1. Received periodontal treatment within the previous 6 months 2. Received systemic antibiotic therapy within the previous 6 months 3. Suffered systemic diseases that could influence therapy outcome (e.g. diabetes mellitus, blood disease) 4. Pregnant |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 30/04/2017 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100020
China
Sponsor information
Hospital/treatment centre
No.8 GongRenTiYuChangNanLu, Department of Stomatology
Beijing Chao-Yang Hospital, Capital Medical University, Chao Yang District
Beijing
100020
China
| Website | http://www.bjcyh.com.cn/ |
|---|---|
"ROR" |
https://ror.org/01eff5662 |
Funders
Funder type
Not defined
No information available
No information available
Results and Publications
| Intention to publish date | 01/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Intending to publish in the Journal of Clinical Periodontology in 2019. |
| IPD sharing plan | The trial individual data were collected and are maintained by the Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. The corresponding author takes full responsibilities for the acquisition, management, analysis, and interpretation of data for this trial. The trial individual data will not be made available to the public but may be available for researchers upon their reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/01/2019 | 15/01/2019 | No | No | |
| Results article | results | 01/05/2019 | 09/08/2019 | Yes | No |
Additional files
- ISRCTN18400416 _BasicResults_04Jan19docx.pdf
- Uploaded 15/01/2019
Editorial Notes
09/08/2019: Publication reference and total final enrolment number added.
15/01/2019: IPD sharing statement added. The basic results of this trial have been uploaded as an additional file.
